This invention relates to the packaging of medical components. More particularly, this invention relates to sterile packages of medical equipment and devices used in heart surgery.
Various sterile packages are used to hold medical components (i.e., devices and equipment) or instruments for surgical procedures. One type of packaging is a molded or thermo-formed sterilized substantially rigid plastic container capable of holding various components. Another type is a flexible pouch into which equipment and supplies can be inserted. The necessary supplies and equipment for a particular surgery are packaged together, sterilized, and delivered to the operating room ready for use.
The current method of packaging oxygenators (i.e., equipment to substitute for lung function during heart by-pass surgery) typically is xe2x80x9cbaggingxe2x80x9d the device in a flexible permeable bag. The device in the bag may be supported by formed plastic within the bag. Supports outside the bag may also used. Such include formed or die-cut foam, die-cut corrugated paperboard, or formed plastic. The flexible permeable bag seals in the oxygenator and acts as a sterile barrier. However, maintaining a sterile barrier with a flexible bag is difficult for a device such as an oxygenator, which may weigh as much as about 6 lb. (2.7 kg), and which contains multiple sharp protrusions (e.g., ports, stopcock manifolds, and mating edges of rigid plastics). Moreover, a flexible bag functions poorly in distributing forces of the oxygenator within the bag, creating pressure points vulnerable to vibrational friction and shock. In addition, the bag can be damaged during handling (before surgery) when the bag and its contents are removed from its shipping container.
Oxygenators are part of perfusion systems used in heart surgery. Similar packaging issues have arisen for perfusion equipment other than oxygenators. Perfusion systems typically contain one or more of an oxygenator, tubing sets, filters, blood reservoirs, sensors, connectors, blood cooling coils and other items comprising an extracorporeal blood circuit that may be used in heart by-pass procedures.
A technician assembles and packages the components of a perfusion system to the specifications of a particular hospital, typically as defined by the surgical team. Thus there are a variety of types of such packages on the market and the components of these packages may very greatly. For example, in addition to the variability in the number and type of components present in the package, the components may be connected in a sequence and with varying lengths of tubing as specified by the surgical team. It is frequently desirable to provide the packages xe2x80x9cpre-connectedxe2x80x9d, so that very little, if any, set up of the packaged components is required.
One currently available perfusion package is a rigid thermoformed container with a rigid inner tray securely taped within the container. The inner tray holds the necessary components and devices of the perfusion package by various shaped holders, adhesive tapes, and fasteners. The container is sealed with a breathable covering, such as a polyethylene membrane (such as that commercially available under the trade designation TYVEK(trademark) from E.I. DuPont deNemours and Co.). A breathable covering permits sterilization of the package with ethylene gas.
Another commercial product is a two-tiered system having a rigid thermoformed plate separating the tubing sets on the bottom tier of a rigid container from the oxygenator and pump lines on the top tier. The contents of the package are secured by using shrink-wrap film. The entire tray is covered with sterile surgical paper and sealed in a breathable bag. The system is sterilized and then shipped to the customer.
Yet another packaging system is a semi-rigid corrugated plastic tray that has metal framing to provide added support to the tray. Devices and components are strapped within holders or formed parts that are adhered to the floor of the tray and secured with mechanical fasteners. Once the tray has been packed, it is covered with a corrugated plastic lid. The entire system is placed into a breathable sterile barrier bag for sterilization before use.
Current packaging systems share some disadvantages. Current systems typically are packed to each customer""s specifications so each package may have different components in it. There is no defined position in the package for a component. Typically the technician who is packing perfusion equipment loads in the medical components and restrains them from movement by means of various fasteners. Because of this, the systems are not only time-consuming to pack but operator inconsistencies develop because of variable placement of the components. These disadvantages also lead to more costly assembly time.
Disposal of the package, once the components in the package have served their use in surgery, can also be problematic. Typically, the components and the package are placed in bags or pouches for removal and disposal. This also is an additional expense and can be time consuming.
Thus, a need in the art exists for a packaging system for medical components which provides ease of assembly and use, adequate support and cushioning for the components, the ability to vary the types of components without changing the package, and a way to dispose of the package inexpensively and conveniently.
This invention is an integrated package particularly suited to the packaging of medical devices and surgical equipment including devices and equipment used in heart by-pass surgery. The package comprises a container and a snap-fit lid. The lid is positioned in the opening of the container and pushed into position. A projection on the container and a groove on the lid provides a xe2x80x9csnap-fitxe2x80x9d of the lid to the container.
In a first aspect, this invention is a packaging system for medical components comprising a container having a bottom surface, first and second opposing sidewalls and third and fourth opposing sidewalls, the bottom surface and sidewalls being connected to form an interior surface of the container such that an opening is formed in the container opposite the bottom surface, the opening being defined by a top edge of the sidewalls, the sidewalls having a circumferential projection in the direction of the interior surface; and a lid having a first side and a second side and a perimeter section sized to fit within the opening in the container, the perimeter section having at least one circumferential groove, the lid being configured to attach to the container in a manner that covers the opening in one of a first mode where the second side of the lid is oriented toward the interior surface of the container and a second mode where the first side of the lid is oriented toward the interior surface of the container, the at least one groove being configured to accommodate the projection when the lid is attached in the first mode and when the lid is attached in the second mode.
The circumferential projection may be continuous and the groove may be continuous. In a preferred embodiment, there are two grooves on the lid. In another preferred embodiment, one of these grooves is continuous and the other groove is provided with at least one channel. Preferably, the projection is substantially parallel to the top edge of the sidewalls and the projection is located adjacent the top edge of the sidewalls. When the lid is attached in the first mode, the interior surface of the container and the second side of the lid define a first enclosed volume and when the lid is attached in the second mode, the interior surface of the container and the first side of the lid define a second enclosed volume wherein the first volume is less than the second volume.
In a second aspect, this invention is a packaging system for medical components comprising a container having an interior surface and an opening; a lid configured to attach to the container in a manner that covers the opening, the lid having a shipping side and a disposal side; and means for attaching the lid to the container such that the lid may be attached to the container with the disposal side facing the interior surface or with the shipping side facing the interior surface.
In a third aspect, this invention is a packaging system for medical components comprising a container having a bottom surface, and sidewalls including first and second sidewalls, the bottom surface and sidewalls being connected such that an opening in the container is formed opposite the bottom surface, the first and second sidewalls including at least one rib; a lid configured to cover the opening in the container; and an insert configured for mounting on one of the first and second sidewalls, the insert having a surface configured to be securely affixed to the rib of the first sidewall when the insert is mounted on the first sidewall and to be securely affixed to the rib of the second sidewall when the insert is mounted on the second sidewall.
Preferably, the insert is removably secured to the at least one rib. The rib may have a V-shape. The insert may be a folding plate. The lid may have a topography adapted to conform to the shape of the medical components in the container and the insert may have a topography adapted to conform to the shape of medical components held by the insert.
In a fourth aspect, this invention is a packaging system for medical components, comprising a container having an interior surface and an opening; a lid configured to attach to the container in a manner that covers the opening; and means for securing the medical components within the container.
In a fifth aspect, this invention is a packaging system for medical components comprising a container having an interior surface and an opening, the interior surface having first and second protrusions; a lid configured to attach to the container in a manner that covers the opening; and an insert configured for selective mounting in multiple locations within the container including adjacent one of the first and second protrusions, the insert having a surface configured to be securely affixed to the first protrusion when the insert is mounted adjacent the first protrusion and to be securely affixed to the second protrusion when the insert is to be mounted adjacent the second protrusion.
In a sixth aspect, this invention is a method of packaging medical components comprising supplying a packaging system including a container having an interior surface and an opening, the interior surface having at least one protrusion, a lid configured to attach to the container in a manner that covers the opening, and an insert having a surface configured to connect with the at least one protrusion and to conform to the surface contour of a medical component; placing a medical component within the container with a surface contour of the medical component conforming to the surface of an insert which is connected to the protrusion; and attaching the lid to the container to secure the medical component within the container.
In a seventh aspect, this invention is a method of disposing of used medical components comprising supplying a packaging system for shipment of the medical components, the packaging system comprising a container having an interior surface and an opening, and a lid configured to attach to the container in a manner that covers the opening in both a shipping mode in which a first side of the lid faces the interior surface and a disposal mode in which a second side of the lid faces the interior surface; placing the used medical components in the container in which they were shipped; covering the container with the lid oriented in the disposal mode such that the second side of the lid faces the interior surface.